What Senior Clinical Research Associate Jobs are in South Africa?

• Plan, initiate, monitor, and close-out clinical trial sites, ensuring compliance with Good Clinical Practice (GCP) and all applicable regulations.
• Conduct site visits (routine monitoring, initiation, and close-out) to assess protocol adherence, data integrity, and subject safety.
• Train and mentor junior CRAs and site staff on study protocols, procedures, and regulatory requirements.
• Develop and maintain strong working relationships with investigators, site staff, and internal project teams.
• Review and reconcile clinical data, identify discrepancies, and ensure timely resolution.
• Prepare and present study progress reports to project management and other stakeholders.
• Manage site-level budgets and timelines effectively.
• Ensure accurate and timely completion of source documents and case report forms (CRFs).
• Participate in the development of study-related documents, including protocols, informed consent forms, and investigator brochures.

• Bachelor's degree in a life science, nursing, or a related scientific field. Advanced degree (Masters or PhD) preferred.
• Minimum of 5 years of direct experience as a Clinical Research Associate in the pharmaceutical industry.
• Demonstrated knowledge of ICH-GCP guidelines and regulatory requirements in South Africa and globally.
• Proven experience in managing multiple clinical trials simultaneously across various therapeutic areas.
• Excellent understanding of clinical trial operations, drug development processes, and pharmaceutical research.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Exceptional organizational and time management abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Excellent written and verbal communication skills in English.
• Willingness to travel up to 60% of the time within **Johannesburg** and surrounding areas as required.

• Competitive annual salary package.
• Comprehensive medical and retirement benefits.
• Opportunities for professional development and career advancement.
• Generous paid time off and sick leave.
• Access to state-of-the-art research facilities.
• A collaborative and supportive work environment in **Johannesburg** contributing to impactful medical advancements.

Our client is a rapidly growing pharmaceutical company dedicated to developing innovative treatments for unmet medical needs. They are seeking a diligent and experienced Clinical Research Associate (CRA) to join their team in Tembisa, Gauteng . As a CRA, you will play a crucial role in ensuring the quality, integrity, and ethical conduct of clinical trials. You will be responsible for monitoring clinical sites, verifying data accuracy, and ensuring compliance with study protocols and regulatory requirements. This position is essential for the successful execution of our clinical development programs, contributing directly to bringing life-saving therapies to patients. This is a fantastic opportunity to advance your career in clinical research within a supportive and growth-oriented organization.

• Monitor assigned clinical trial sites to ensure compliance with Good Clinical Practice (GCP), protocol, and regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
• Conduct site initiation, routine monitoring, and close-out visits.
• Build and maintain strong relationships with investigators and site staff.
• Ensure timely reporting of study progress, deviations, and adverse events.
• Train site personnel on study-specific procedures and regulatory compliance.
• Manage study supplies and investigational product at assigned sites.
• Assist in the preparation of regulatory submission documents and site regulatory files.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree or equivalent experience is preferred.
• Minimum of 3 years of experience as a Clinical Research Associate, preferably within the pharmaceutical or biotechnology industry.
• Thorough understanding of clinical trial processes, GCP, ICH guidelines, and local regulatory requirements.
• Proven ability to manage multiple sites and study tasks effectively.
• Excellent communication, interpersonal, and organizational skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required within the Gauteng region.
• Strong problem-solving skills and attention to detail.
• Commitment to ethical conduct and patient safety.

This role offers a competitive salary, comprehensive health and wellness benefits, and a structured professional development program. Our client invests in their employees, providing opportunities for growth and advancement within the organization. You will be part of a collaborative team dedicated to making a real difference in healthcare. The position is based in Tembisa, Gauteng , providing excellent accessibility. Join a company that values integrity, innovation, and teamwork, and contribute to significant advancements in medical treatment.

• Conduct pre-study, initiation, interim, and close-out visits for clinical trial sites.
• Monitor clinical trial data and source documentation to ensure accuracy, completeness, and adherence to protocols and GCP.
• Verify patient safety and adherence to inclusion/exclusion criteria.
• Manage site start-up activities, including essential document collection and IRB/EC submissions.
• Train and mentor site staff on protocol requirements, study procedures, and data collection.
• Ensure timely resolution of site issues and data discrepancies.
• Communicate effectively with investigators, site staff, internal study teams, and regulatory authorities.
• Prepare comprehensive monitoring visit reports and follow-up on action items.
• Contribute to the development and review of clinical study protocols, informed consent forms, and other study-related documents.
• Ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA, SAHPRA).

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate, with a significant portion focused on Oncology trials.
• Thorough understanding of ICH-GCP guidelines and other relevant regulatory requirements.
• Proven experience in on-site monitoring and site management.
• Excellent understanding of oncology disease processes and clinical trial designs.
• Strong organizational, time management, and problem-solving skills.
• Excellent written and verbal communication skills, with strong interpersonal abilities.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel frequently (up to 60%) to clinical sites, including overnight stays.
• Valid driver's license and willingness to travel within the assigned region.

• Conduct site feasibility assessments and pre-study visits to identify suitable investigative sites.
• Initiate, monitor, and close out clinical trial sites according to study protocols, GCP, and relevant regulations.
• Ensure the quality and integrity of clinical trial data collected at investigator sites.
• Verify that investigational products are stored, dispensed, and accounted for correctly.
• Train site staff on protocol requirements, study procedures, and regulatory compliance.
• Identify and resolve site-level issues and escalate critical issues to the project manager as needed.
• Ensure timely submission of study-related documentation and reports.
• Maintain effective communication with investigators, site staff, and internal project teams.
• Perform source data verification (SDV) and query resolution.
• Ensure adherence to budget and timeline commitments for site management activities.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
• A minimum of 5 years of experience as a Clinical Research Associate, with demonstrated experience in monitoring clinical trials.
• Thorough understanding of ICH-GCP guidelines and other relevant regulatory requirements.
• Proven ability to manage multiple clinical trial sites and complex study protocols.
• Excellent organizational, time management, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to interact effectively with healthcare professionals.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness and ability to travel extensively within the **Polokwane** region and potentially beyond.
• Experience in a hybrid work environment, managing remote tasks and on-site responsibilities.
• Certification as a CRA (e.g., ACRP, SoCRA) is a plus.

• Conduct site selection, initiation, interim monitoring, and close-out visits for clinical trials.
• Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
• Ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols.
• Manage communication between investigators, study coordinators, and the sponsor.
• Train and support site staff on study procedures, protocol requirements, and data collection.
• Monitor subject recruitment and retention, and implement strategies to address any shortfalls.
• Identify and report any adverse events (AEs) or serious adverse events (SAEs) according to study procedures and regulatory guidelines.
• Maintain accurate and organized study documentation and site files.
• Prepare site monitoring visit reports and follow up on action items.

• Bachelor's degree in a life science, nursing, pharmacy, or related field.
• Minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements governing clinical trials.
• Experience in monitoring studies across various therapeutic areas is preferred.
• Excellent interpersonal, communication, and presentation skills.
• Strong organizational and time management skills, with the ability to prioritize effectively.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Willingness and ability to travel extensively (estimated 60-70% of the time) within the assigned region.
• Valid driver's license and access to a reliable vehicle.

• Competitive annual salary and performance-based bonuses.
• Comprehensive medical and retirement benefits.
• Travel allowance and accommodation support during site visits.
• Opportunities for professional development and training in clinical research.
• Supportive team environment and mentorship.
• Contribution to impactful pharmaceutical research and development.

Our client, a dynamic Contract Research Organization (CRO) specializing in clinical trials, is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their expanding team in Vereeniging, Gauteng . This role is essential for managing and monitoring clinical trial sites, ensuring the integrity, accuracy, and compliance of data collected during studies. The CRA will work closely with investigators, site staff, and internal project teams to facilitate the successful execution of clinical trials. This is an excellent opportunity to advance your career in clinical research and contribute to the development of life-saving medicines.

• Conduct site initiation, routine monitoring, and close-out visits to clinical trial sites.
• Ensure compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical data through source document verification.
• Manage site communication, provide ongoing support to investigators and site staff, and resolve site-level issues.
• Monitor subject recruitment and retention, implementing strategies to meet study timelines.
• Ensure proper drug accountability and investigational product management at study sites.
• Prepare detailed monitoring visit reports and track action items to resolution.
• Facilitate regulatory inspections and audits of study sites.
• Maintain accurate and up-to-date site-specific documentation in the Trial Master File (TMF).
• Contribute to protocol development and site selection activities as needed.

• Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
• Thorough understanding of GCP, ICH guidelines, and local regulatory requirements for clinical trials.
• Demonstrated experience in site monitoring, data verification, and regulatory compliance.
• Excellent communication, interpersonal, and organizational skills.
• Ability to manage multiple priorities and work effectively under pressure.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel extensively to clinical sites as required (approx. 60-70%).
• Strong problem-solving skills and a proactive approach to identifying and resolving site issues.
• A valid driver's license and a reliable vehicle are essential.

Our client offers a competitive salary, performance-based bonuses, a company car or travel allowance, comprehensive medical and retirement benefits, and extensive training opportunities. This role provides significant exposure to diverse clinical trials and therapeutic areas. The position is based in Vereeniging, Gauteng , with opportunities for growth within a reputable CRO.